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Referral: Valproate and related substances
sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide, associated names: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/03/2018, EC decision date: 31/05/2018, Last updated: 07/06/2018Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … Chrono Convulex Delepsine Depakin Depakine Depakote Depamag Depamide … Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … -
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Referral: Valproat Ratiopharm Chrono
valproic acid, valproate, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 25/05/2010, EC decision date: 26/05/2010, Last updated: 23/07/2012various trade names including Depakine/Deprakine, Depakote and Epilim, and … various trade names including Depakine/Deprakine, Depakote and Epilim, and … -
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Referral: Valproate
valproic acid, valproate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/12/2009, EC decision date: 26/08/2010, Last updated: 29/04/2011various trade names including Depakine/Deprakine, Depakote and Epilim, and … various trade names including Depakine/Deprakine, Depakote and Epilim, and … -
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Press release: PRAC recommends new measures to avoid valproate exposure in pregnancy
PRAC, Last updated: 09/02/2018Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … -
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Press release: New measures to avoid valproate exposure in pregnancy endorsed
CMDh, Last updated: 23/03/2018Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … -
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Press release: PRAC recommends strengthening the restrictions on the use of valproate in women and girls
PRAC, Last updated: 10/10/2014Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … -
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Referral: Valproate and related substances
sodium valproate, valproic acid, valproate semisodium, valpromide, associated names: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel, Article 31 referrals
Status: CMDh final position, opinion/position date: 19/11/2014, Last updated: 29/01/2015Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … -
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Human medicine European public assessment report (EPAR): Inovelon
Rufinamide, Epilepsy
Date of authorisation: 16/01/2007, Revision: 22, Authorised, Last updated: 17/08/2021 -
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Referral: Didanosine
didanosine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/09/2013, EC decision date: 20/11/2013, Last updated: 10/12/2013Aurobindo 200mg capsule rigide gastroresistenti 200 mg Gastro-resistant … Aurobindo 250mg capsule rigide gastroresistenti 250 mg Gastro-resistant … Aurobindo 400mg capsule rigide gastroresistenti 400 mg Gastro-resistant … -
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Referral: Lansoprazol-ratiopharm 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006 -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015 -
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Referral: Zyrtec
cetirizine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 30/05/2008, EC decision date: 06/10/2008, Last updated: 16/10/2008 -
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Referral: Baxter dialysis solutions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, Last updated: 20/11/2013 -
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Referral: Ciprofloxacin Hikma
ciprofloxacin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/01/2007, EC decision date: 11/06/2007, Last updated: 06/09/2007Ciprofloxacin Hikma 200mg/100ml Soluzione per Infusione Endovenosa … -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Referral: Losec
omeprazole, associated names: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole, AstraZeneca, Zoltum, Article 30 referrals
Status: European Commission final decision, opinion/position date: 20/01/2010, EC decision date: 10/06/2010, Last updated: 19/09/2011 -
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Referral: Bleomycin
bleomycin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 12/03/2009, Last updated: 31/03/2009 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Orphan designation: Cysteamine bitartrate (gastroresistant) (mercaptamine) for: Treatment of cystinosis
Date of designation: 20/09/2010, Positive, Last updated: 10/10/2013 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Orphan designation: Octreotide chloride for: Treatment of acromegaly
Date of designation: 12/06/2009, Positive, Last updated: 30/05/2018 -
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Orphan designation: ciclosporin for: Treatment of atopic keratoconjunctivitis
Date of designation: 24/07/2009, Positive, Last updated: 11/09/2009 -
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Orphan designation: Dexamethasone phosphate for: Treatment of corneal graft rejection
Date of designation: 15/05/2009, Withdrawn, Last updated: 21/10/2016 -
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Orphan designation: carmustine for: Treatment of glioma
Date of designation: 05/03/2002, Withdrawn, Last updated: 17/10/2013γλοιώματος Italian Carmustina (soluzione iniettabile per via intratumorale … -
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List of medicines under additional monitoring
Last updated: 25/05/2022